The Retailer Spring Edition 2023

SPRING 2023

49

MoCRA Implementation Timeline

2023

2024

2025

2026

Product Listing

Facility Registration

Reporting Adverse Events

Safety Substantiation

Labelling Updates

Fragrance Allergen Rule

GMP Rule

Details to be confirmed Compliance deadline/final rule

3. Mandatory Reporting of Adverse Health Events The U.S. RP must manage all adverse event reports related to their cosmetic products and submit any report of a serious adverse event to the FDA within 15 days. This will require companies to establish clear internal procedures for managing all adverse and serious adverse events or outsource this expertise. This requirement is expected to take effect during 2024. 4. Safety Substantiation for Cosmetic Products Effective starting December 29, 2023, the RP must maintain records supporting that each cosmetic product has “adequate substantiation of safety.” The term adequate substantiation of safety is defined in Section 608(c)(1) as “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.’’ Further clarity on the expected content and data requirement for a U.S. cosmetic safety assessment is expected this year. There may be a new requirement for testing beyond what is currently required by the EU By the end of 2024, all cosmetic products must be labelled with a U.S. domestic address, telephone number, or electronic contact information for the RP. The FDA also plans to introduce mandatory labelling of fragrance aller gens. While this is already a requirement for cosmetic products in the EU and UK, it is uncertain whether the FDA will adopt the same list of allergens and threshold levels as the EU. More information on this is expected during 2024. It is imperative for all global companies selling cosmetic products in the U.S. to begin preparing as soon as possible.” ‘‘ and UK for a cosmetic product safety assessment. 5. Mandatory Product Labelling Information

WHAT PRACTICAL FIRST STEPS CAN COMPANIES TAKE NOW TO START PREPARING FOR MoCRA? These new regulations will have significant implications for all UK and global companies selling cosmetic products in the U.S. It is crucial for businesses to begin to understand these changes now and how they will impact their products and business plans. Exponent, along with other industry leaders, emphasises the impor tance of prioritising consumer safety, especially due to the high level of expertise needed to meet MoCRA requirements and the increased risk of non-compliance and resulting litigation. For many companies, this may require new employee hires with regulatory or toxicology exper tise or outsourcing work to reputable external agencies for regulatory, toxicology, and testing services to ensure compliance. Exponent can help businesses review product ranges, identify potential compliance gaps, and get plans in place to comply with MoCRA.

Tracey Fanning tfanning@exponent.com exponent.com/people/tracey-fanning Claire Fordyce cfordyce@exponent.com exponent.com/people/claire-fordyce Iain Brunning ibrunning@exponent.com exponent.com/people/iain-brunning